药物非临床安全性评价毒性试验有害作用的判断非常重要，因其可为保护临床试验暴露于新化学实体或药物的受试者提供重要信息。毒性试验组织病理学检查可提供受试物毒性作用的形态学数据，帮助分析和确定有害作用和非有害作用及其剂量水平。参照美国毒性病理学会（STP）和欧洲毒性病理学会（ESTP）的推荐最佳实践或建议及其他相关文献，对有害作用的定义、区分有害作用与非有害作用的要素、有害作用数据沟通和使用来评估人类潜在风险等建议等进行简要概述分析，以期为我国非临床药物安全性评价毒性试验中有害作用判定提供参考。

The determination of adverse effects is crucial in the toxicity studies of nonclinical safety evaluation of drugs because it can provide important information for protecting the health of subjects exposed to new chemical or pharmaceutical entities during clinical trials. Histopathological examination can provide morphological data on the toxic effects of the test article to help the analysis and determination of adverse and non-adverse effects, as well as their dose levels. This paper briefly summarizes and analyzes the definition of adverse effects, discriminating key factors used to differentiate non-adverse effects from adverse effects, the recommendations for the communicating and use of adverse effect data in assessing potential human risk, which refers to the recommended best practices/suggestions of Society of Toxicologic Pathology (STP) and European Society of Toxicological Pathology (ESTP), and other relevant references, in order to provide some references for determining adverse effects in the toxicity studies during nonclinical safety evaluation of drugs in China.

江苏省新药一站式高效临床前评价公共服务平台建设项目（BM2021002）